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Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson, has recalled an estimated 200,000 units of anti-fungal Grifulvin V because of two reports that glass fragments were found in bottles of the oral suspension, the firm announced April 10.
Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson, has recalled an estimated 200,000 units of anti-fungal Grifulvin V because of two reports that glass fragments were found in bottles of the oral suspension, the firm announced April 10.
Perrigo is recalling 11 million bottles of 500-mg acetaminophen caplets after its metal detectors revealed small metal fragments in some of the product, which it manufactured and distributed under various store brands.
The FDA's decision to issue 45 Class I recalls over the past fiscal year signals a fundamental shift in enforcement policy for an agency still reeling from criticism over recent drug safety incidents, experts say.
CDER performed 45 Class I recalls of human drugs deemed to have “very serious potential to cause harm, injury or death” in the last fiscal year, according to Joe Famulare, acting deputy director of CDER’s Office of Compliance.
CDER performed 45 Class I recalls of human drugs deemed to have “very serious potential to cause harm, injury or death” in the last fiscal year, according to Joe Famulare, acting deputy director of CDER’s Office of Compliance.